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Spire Biomedical, Inc.'s Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

The Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis. the arterial lumen of the catheter is shorter than the venous lumen at the catheter's distal end. The catheter has a felt cuff and dual extensions. Each extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter:

Summary of Device and Context:

The "Decathlon™ Kuhle Twin Lumen Chronic Hemodialysis Catheter with Separated Tips" is a radiopaque polyurethane catheter designed for chronic hemodialysis and apheresis. It is intended for percutaneous insertion. This 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). The key difference in the proposed device is a "small angle" divergence of the lumens at the distal end, compared to the predicate's "substantially parallel" lumens.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device. The core argument is that the single design change (angle of distal lumen divergence) is minor enough not to alter the established safety and effectiveness characteristics of the predicate.

Study Information:

The provided document describes a comparison study to a legally marketed predicate device, rather than a de novo clinical or extensive performance study.

• 2. Sample Size Used for the Test Set and Data Provenance:

  • Test Set Sample Size: Not explicitly stated as a separate test set. The submission relies on data from the predicate device. If "test set" refers to the new device itself, there's no mention of a specific number of new devices being tested for this submission.
  • Data Provenance: The data provenance is from the predicate device (Spire Biomedical, Inc.'s 15.5Fr Decathlon™ Twin Lumen Hemodialysis Catheter with Separated Tips, K032061, K042858). It appears to be retrospective in the sense that existing data from a previously cleared device is being leveraged. The country of origin of the data is not specified, but the submitter is based in the USA.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

  • Not applicable. This was not a study requiring expert-established ground truth in the typical sense (e.g., for diagnostic accuracy). The comparison is against engineering specifications and existing regulatory clearance of a predicate device.

• 4. Adjudication Method for the Test Set:

  • Not applicable. There was no specific "adjudication" (e.g., expert consensus on clinical cases) for a test set. The review process was a regulatory submission evaluated by the FDA.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No, an MRMC comparative effectiveness study was not done. This device is a physical medical device, not an AI or diagnostic imaging tool that would typically involve human readers.

• 6. Standalone (Algorithm Only) Performance Study:

  • No, a standalone performance study in the context of an algorithm or AI was not done. This is not an algorithmic device.

• 7. Type of Ground Truth Used:

  • The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device, as demonstrated through its mechanical, physical, and biocompatibility tests that led to its previous FDA clearance (K032061, K042858). The manufacturer is asserting that the minor design change in the new device does not alter this established ground truth.

• 8. Sample Size for the Training Set:

  • Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

• 9. How the Ground Truth for the Training Set Was Established:

  • Not applicable, as there is no training set for an AI/machine learning model. The underlying "ground truth" for the predicate device would have been established through a combination of engineering specifications, material testing, mechanical testing, and biocompatibility studies conducted according to relevant standards at the time of its original clearance.

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Spire Biomedical, Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.

The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.

Here's a summary of the acceptance criteria and the studies related to the Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

• Pressure increase in the arterial lumen
• Visual evaluation of the catheters
• End-point thrombus accumulation | "Results show improved thromboresistance using each of these criteria for Decathlon Coated catheters vs. uncoated catheters." |
  | Mitigation of Specific Thrombus Types | Effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft). | "The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft)." |
  | Mechanical/Physical/Biocompatibility | The device's small change (angle between distal end lumens) is not expected to alter the characteristics of the catheter, therefore predicate device data is acceptable. | "Mechanical, physical, and biocompatibility tests were conducted on the predicate device. These tests were not repeated for this submission since this small change (angle between distal end lumens) does not alter any of the characteristics of the catheter. Test data from the predicate device is contained in this application." (Predicate device: Spire Biomedical, Inc.'s (K060155) 15.5Fr Decathlon™ Gold Twin Lumen Hemodialysis Catheter with Separated Tips). |

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • 90-day durability tests (Heparin Coating Bioactivity): The sample size isn't explicitly stated for this particular part. It mentions "coated catheters" in saline, with measurements at "7 regular intervals." The study type appears to be prospective (in-vitro). No country of origin is mentioned.
   • In-vitro thromboresistance study: One coated and one uncoated catheter per test. The study involved circulation of bovine blood. This is an in-vitro, prospective study. No country of origin is mentioned.
   • Animal study (Ovine Model): "One coated and one uncoated catheter was evaluated in each of three animals (ovine)." This is an animal study, prospective. No country of origin is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • The document does not mention the use of human experts to establish ground truth for the performance studies. The ground truth appears to be objective laboratory measurements (heparin bioactivity, thrombus accumulation via radiolabeled measurements and weight measurements, visual evaluation, pressure increase).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable, as human expert adjudication is not mentioned for establishing ground truth in these performance studies.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No MRMC comparative effectiveness study was done. This device is a medical catheter, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The ground truth used for performance evaluation was based on objective laboratory measurements and animal study observations/measurements:
     • Heparin bioactivity (in pmol/cm').
     • Total thrombus accumulation (radiolabeled measurements, thrombus weight measurements).
     • Pressure increase in the arterial lumen (in-vitro).
     • Visual evaluation of catheters (in-vitro and animal study).
     • Optical and scanning electron microscopy (animal study).

7. The sample size for the training set

   • Not applicable. This is a physical medical device, not an AI model that requires a training set.

8. How the ground truth for the training set was established

   • Not applicable.

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Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Indications for Use: Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter is processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Alta Gold, Heparin Coated Catheter is fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the ends of the distal tips; the cuff is not coated).

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

Acceptance Criteria and Study for K063441: 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter

This document describes the acceptance criteria and the study that proves the Spire Biomedical, Inc.'s 15.5Fr Alta Gold, Twin Lumen Fixed Tip Coated Chronic Hemodialysis Catheter meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The primary performance studies for the Alta Gold catheter leveraged data from previously cleared devices, particularly the 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter (K060155), due to identical material, outside dimensions, and coating.

• In-vitro durability test (90-day bioactivity): Not explicitly stated, but performed on "coated catheters in saline."
• In-vitro thromboresistance study (2-hour blood loop): Involved "circulation of bovine blood" through an outer loop with "coated or uncoated catheter." The number of catheters tested is not specified but it's a comparative study. This study was performed on the Alta Gold catheters, while other tests were performed on the predicate Decathlon Gold catheters.
• Biocompatibility Testing: Conducted on the 15.5Fr Decathlon coated catheter. Number of samples not explicitly stated but implied to be sufficient for ISO 10993 compliance.

Data Provenance:
All studies mentioned are in-vitro laboratory studies, and thus the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the same way as for clinical trials with human subjects. The studies were conducted by Spire Biomedical, Inc. (or their contractors) in support of regulatory submission in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This submission does not involve a standard clinical study with expert interpretation of cases. The "ground truth" for the performance claims is established through objective, quantitative, in-vitro scientific measurements and validated international standards (e.g., ISO 10993). Therefore, there were no "experts" in the traditional sense establishing a diagnostic ground truth for a test set of medical images or patient data. The scientists and technicians conducting the laboratory tests provided the data.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used as this was not a study involving human interpretation of medical data requiring consensus or arbitration. The performance data was derived from laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a chronic hemodialysis catheter, not an algorithm or AI system. Its performance is inherent to the device's material properties and coating, not dependent on an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on:

• Quantitative In-vitro Measurements: Direct measurements of heparin bioactivity (pmol/cm²), thrombus accumulation (radiolabeled measurements), pressure increase, and visual evaluation in controlled laboratory settings.
• Adherence to Standards: Compliance with established physical and mechanical test methods, and international biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore no "training set" was used. The device's design and performance are based on engineering principles and established biological interactions, not data training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

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Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated). The distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.

The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.

The provided text describes a 510(k) summary for a medical device, the 15.5Fr Decathlon Gold, Coated Catheters with funnel tips. However, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study.

The document focuses on:

• Device Description: Details about the catheter's design, material (polyurethane with Carmeda® BioActive Surface (CBAS®) coating), and the "funneled" distal tips.
• Product Claims:
  • Maintains heparin's bioactive properties for a minimum of 90 days (demonstrated in two in-vitro studies).
  • Coating reduces total thrombus accumulation by 51% compared to uncoated catheters (demonstrated in an in-vitro thromboresistance study).
• Technological Characteristics Comparison to Predicate Devices: States that the device is identical to a predicate device (K060155) in materials, dimensions, and coating, with the only difference being the funneled distal tips.
• Performance Data: Refers to in-vitro blood loop testing and catheter flow bench testing as additional tests performed specifically for this device (Decathlon Gold with funnel tips), while other tests (stability, durability, mechanical properties) were performed on the predicate device and not duplicated.
• Predicate Devices: Lists several legally marketed devices that use the same Carmeda® BioActive Surface (CBAS®) coating.

Based on the provided text, I cannot answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI assistance, sample sizes for training/test sets, ground truth establishment, or multi-reader multi-case studies.

The "studies" mentioned are in-vitro studies demonstrating the coating's properties (bioactivity duration, thrombus reduction) and do not involve human readers, AI, or clinical outcomes that would typically have acceptance criteria in the format requested. The document does not provide a table of acceptance criteria or specific performance against such criteria.

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To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.

The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.

The provided K062435 document describes a 510(k) premarket notification for a "Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters." This device is a repair kit for existing medical catheters, and the submission focuses on demonstrating substantial equivalence to a predicate device, the Pourchez Retro Repair Kit (K022644).

Given the nature of this submission (a repair kit for existing catheters, demonstrating equivalence to an existing repair kit), the "study" conducted is a series of bench tests rather than a clinical trial involving human or animal subjects that falls under a typical AI/ML performance study. The focus is on physical and material characteristics.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment for AI, expert involvement, MRMC studies, standalone AI performance) are not applicable to this type of device and submission. The "acceptance criteria" and "device performance" in this context refer to the physical and mechanical properties tested during bench validation.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 'Bench Testing' for physical test data."

However, Section 18 "Bench Testing" is not included in the provided excerpts. Therefore, the specific acceptance criteria and the quantitative reported performance values are not available here. We can infer that the general acceptance criterion would be that the repair kit's performance in these physical tests is equivalent to or not worse than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided document. For physical bench testing, sample sizes vary depending on the specific test and statistical requirements.
• Data Provenance: The tests were conducted "in-house" by Spire Biomedical, Inc. (manufacturer), likely at their facility in Bedford, MA, USA. This is a retrospective evaluation based on laboratory testing of the device prototypes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For physical bench testing of a medical device repair kit, "ground truth" is typically established by engineering specifications, material standards, and benchmark performance of predicate devices, not by expert consensus on clinical data. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are relevant for subjective assessments, such as image interpretation or clinical outcomes, typically involving multiple human readers. Bench testing involves objective measurements against established technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not Applicable. This device is not an AI/ML-driven diagnostic or assistive tool for human readers. It's a physical medical device repair kit.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

• Not Applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• For physical tests: Engineering specifications, material standards, and benchmark performance data of the predicate device (Pourchez Retro Repair Kit K022644).
• For biocompatibility: Adherence to recognized biocompatibility standards (e.g., ISO 10993 series) for medical devices.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set." The repair kit itself is the "device," designed and manufactured according to specifications.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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Spire Biomedical Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion. The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ are radiopaque silicone catheters that have been coated with silver using a physical vapor deposition process. The silver is applied to the distal end of the catheter from approximately 2-5mm below the cuff to the tips, and is on the exterior surfaces of the catheter only. Aside from the silver coating, the catheters have identical physical characteristics to the non-coated RetrO and XpressO catheters, both of which have 510(k) Premarket Approval. The catheter configurations (available lengths and insertion kit components) are also identical. The silver coating is applied by a vacuum-based physical vapor deposition process called ion beam assisted deposition (IBAD). IBAD combines evaporation with concurrent ion beam bombardment. The process is performed under a high vacuum environment. A silver vapor is formed via electron beam evaporation and deposited onto the catheter. Simultaneously, energetic ions bombard the catheter surface and coating as it is deposited. The coating consists of three layers: titanium, palladium, and silver. The film layers are deposited sequentially with the titanium and palladium layers being completely covered by the silver.

This document, K060288, describes the Spire Biomedical, Inc.'s RetrO Silver™ and XpressO Silver™ Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The key performance claim for these devices is the silver coating's ability to reduce bacterial surface colonization for up to two months.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

For the reduction of bacterial surface colonization, the document refers to a published clinical study by Bambauer et al. (2001). The sample size and specific details of the test set for this study are not provided in the submission itself, but would be found in the referenced publication. The data provenance is implied to be clinical, but the country of origin is not specified in this document. It is a retrospective reference to existing literature.

For frictional resistance, silver coated catheters and uncoated catheters were compared. The document doesn't specify the exact number of catheters in the test set, but states "Tests were conducted at several different normal load conditions" and "All measurements were conducted in the dry state." This was a prospective in-vitro bench test.

For silver elution rates, "segments were cut from the shafts of silver coated catheters" and "Tests were performed in triplicate for periods ranging from 1 day to 8 weeks." This was a prospective in-vitro bench test with a sample size of at least three per time point.

For equivalent flows and mechanical properties, these were compared to predicate devices. The document does not specify the sample size but implies an in-vitro equivalence study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For the reduction of bacterial surface colonization, the information is based on a referenced clinical study. The number and qualifications of experts involved in establishing the ground truth (e.g., diagnosing infections, culturing bacteria) for that study are not provided in this 510(k) submission.

For the in-vitro tests (frictional resistance, silver elution rates, flows, mechanical properties), "experts" in the traditional sense of medical diagnoses were not involved. The ground truth was established through laboratory measurement protocols and analyses by qualified technical personnel within Spire Biomedical or a contract lab.

4. Adjudication Method for the Test Set

Given the nature of the evidence provided (reference to a clinical study for bacterial colonization, and in-vitro bench testing for other characteristics), there is no mention of an adjudication method (like 2+1 or 3+1 consensus) in this submission. This type of adjudication is typically relevant for studies involving human interpretation of medical images or symptoms, which is not the primary focus of the performance data presented here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this submission. The device is a physical medical device (catheter), and its performance data focuses on material properties, bacterial colonization rates, and mechanical equivalence, rather than human interpretation or diagnostic aid. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable to this device. The RetrO Silver™ and XpressO Silver™ catheters are physical medical devices, not AI algorithms. Their performance is described in a standalone manner, entirely independent of human-in-the-loop performance in the context of interpretation or decision-making.

7. Type of Ground Truth Used

• Reduction of Bacterial Surface Colonization: The ground truth for this claim is based on clinical testing from referenced literature. This would typically involve microbiological culture results or clinical infection rates.
• Frictional Resistance: The ground truth was established through direct physical measurement using a test rig platform.
• Silver Elution Rates: The ground truth was established through chemical analysis (measuring silver concentration in solution) in laboratory immersion studies.
• Equivalent Flows and Mechanical Properties: The ground truth was established through physical measurements and engineering tests to compare the coated catheters to their non-coated predicate devices.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable. The performance data is derived from direct testing of the physical device or references to clinical studies, not from a model trained on data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this physical medical device, this question is not applicable.

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Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.

The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.

The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.

Catheters longer than 40cm are intended for femoral vein insertion.

Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).

The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.

Acceptance Criteria and Study for 15.5Fr Decathlon Coated Catheters (K060155)

The provided documentation describes the acceptance criteria and supporting studies for the 15.5Fr Decathlon Coated Catheters, which incorporate a Carmeda® BioActive Surface (CBAS®) coating to reduce thrombus formation.

The "device performance" in this context refers to the coating's ability to maintain bioactivity and reduce thrombus. The acceptance criteria are implicitly derived from the product claims and the results of the performed in-vitro and animal studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • In-vitro Thromboresistance Study: Not explicitly stated, but implies multiple coated and uncoated catheters were tested as part of the "circulation of bovine blood through an outer loop."
  • Animal (Ovine) Studies: 3 animals were used for evaluation. Within each animal, one coated and one uncoated catheter were evaluated.
  • 90-day Durability Tests: Not explicitly stated how many catheters were tested, but "coated catheters" were used.
• Data Provenance: The studies were conducted by Spire Biomedical, Inc. (submitter). The country of origin for the studies is not explicitly stated but is implied to be in the USA where the company is located. The studies are prospective in nature as they are specifically designed to test the performance of the new coated catheter.

3. Number of Experts and Qualifications for Ground Truth

• No information provided regarding the number or qualifications of experts involved in establishing ground truth for the provided studies.
  • For the animal studies, examination "using optical and scanning electron microscopy" would likely involve trained histologists or pathologists, but their specific qualifications are not detailed.
  • Visual evaluations in the in-vitro study and interpretation of mechanical/biological data would also involve expert judgment, but again, details are absent.

4. Adjudication Method for the Test Set

• No information provided regarding a specific adjudication method (e.g., 2+1, 3+1). The studies appear to be quantitative (e.g., radiolabeled measurements, thrombus weight) and qualitative (visual evaluation, microscopy) assessments. Expert consensus or arbitration related to the interpretation of results is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was performed. The described studies are focused on the device's inherent biological and physical performance attributes, not on human reader performance with or without AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• Yes, standalone performance studies were done. All described studies (in-vitro, animal, durability, biocompatibility, mechanical properties) evaluate the performance of the catheter itself, without human intervention as part of the primary performance metric. The "algorithm" in this context is the CBAS® coating technology applied to the catheter, and its performance is evaluated directly.

7. Type of Ground Truth Used

• Experimental/Objective Measurements:
  • In-vitro Thrombus Reduction: Radiolabeled measurements (objective quantitative data) and visual evaluation (qualitative observation).
  • In-vivo Thrombus Reduction (Animal Study): Thrombus weight measurements (objective quantitative data), optical microscopy, and scanning electron microscopy (qualitative and semi-quantitative analysis).
  • Coating Durability: Surface-bound heparin bioactivity (pmol/cm2) measurements over time (objective quantitative data).
  • Biocompatibility: Conformance to ISO 10993 requirements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device (catheter) with a bioactive coating, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The coating technology itself is the "algorithm" and its performance is characterized through direct experimentation.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As explained in point 8, there is no "training set" for this device. The ground truth for the device's performance claims is established through the specific experimental methodologies and measurements described in the in-vitro and animal studies.

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The 55cm 15.5Fr Decathlon™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.

The provided text describes a 510(k) summary for the Spire Biomedical 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study to "prove" performance in the way a clinical trial would for a novel device.

The study referenced is a set of engineering and physical tests to show the device's characteristics are similar to predicate devices or meet established standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table style, nor does it provide specific numerical performance data against those criteria. Instead, it makes a general statement of compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the mechanical and physical tests performed. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). These details are typically part of internal design control documentation and test reports, not generally included in a 510(k) summary at this level of detail.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This information pertains to studies involving expert review for determining ground truth (e.g., image interpretation). The reported study is a series of mechanical and physical tests on a medical device, which would involve engineering and laboratory testing against established specifications or standards, not expert adjudication of clinical data.

4. Adjudication Method

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts in clinical studies or data labeling. The reported study involves laboratory testing of physical device properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned or implied. This type of study assesses the performance of human readers, typically with and without AI assistance, on diagnostic tasks over multiple cases. The provided text is about the substantial equivalence of a physical medical device (catheter) through mechanical and physical testing.

6. Standalone (Algorithm Only) Performance

Not Applicable. A standalone performance evaluation is relevant for AI algorithms. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance data in this context would be:

• Engineering specifications for mechanical and physical properties.
• Established ISO standards for hemodialysis catheters.
• The performance characteristics of the legally marketed predicate devices (Spire Biomedical, Inc. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061").

8. Sample Size for the Training Set

Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The study involves testing a physical product.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, there is no ground truth for a training set to establish.

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The 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm can be used for femoral insertion.

55cm Pourchez RetrO™ Silicone Twin Lumen Chronic Device Hemodialysis Catheter with Separated Tips. The 55cm Pourchez RetrO catheter uses the exact same materials of construction.

The provided text is a 510(k) summary for a medical device, the "55cm Pourchez RetrO Kit" or "Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a study involving human-in-the-loop or standalone AI performance.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through engineering and bench testing, rather than extensive clinical trials with human readers or AI.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

   This document does not specify quantitative acceptance criteria. Instead, it asserts that "A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." The "reported device performance" is essentially that these tests did demonstrate substantial equivalence or conformance.

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices (K022000) for mechanical and physical properties.	Demonstrated via mechanical and physical tests (tensile and flow).
   Conformance to established ISO standards for hemodialysis catheters.	Demonstrated via mechanical and physical tests (tensile and flow).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not applicable. The "tests" mentioned are mechanical and physical bench tests, not clinical studies with patients or data sets in the typical sense for AI/human performance. No sample size for a test set (e.g., patient data) is provided, nor is data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Not applicable. Ground truth for device performance in this context would be physical measurements from the aforementioned mechanical and physical tests, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. No MRMC study was performed, as this device (a catheter) is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   The "ground truth" for the performance claims appears to be derived from objective measurements from mechanical and physical bench tests, and conformance to ISO standards for hemodialysis catheters.

8. The sample size for the training set

   Not applicable. This is a physical medical device; there's no "training set" in the context of an AI algorithm.

9. How the ground truth for the training set was established

   Not applicable, as there is no training set mentioned in the context of AI. For the manufacturing and quality control of the physical device, ground truth would be established through engineering specifications and industry standards.

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The 15.5Fr Alta LR Twin Lumen Fixed Tip Hemodialysis Catheter is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The polyurethane 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Decathlon ™ radiopaque polyurethane catheters with similar catheter tip-to-hub lengths of 24cm, 28cm, 32cm, 36cm and 40cm.

This document is a 510(k) summary for the 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter by Spire Biomedical, Inc. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device's performance was evaluated against standards and predicate device performance.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the mechanical and physical tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests were likely conducted in a laboratory setting by Spire Biomedical, Inc.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The "ground truth" here relates to engineering performance specifications and existing standards, not clinical diagnoses requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable to this submission as it relates to clinical studies or interpretations, not the mechanical testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or diagnostic algorithms where human readers are involved in interpretation. The device in question is a physical medical device (catheter), and its evaluation relies on mechanical and physical performance tests, not AI-assisted human reading.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. This device is not an AI algorithm. Its performance is evaluated through physical and mechanical testing of the device itself.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance was:

• Comparison to the performance of the predicate device (Spire Biomedical, Inc.'s Decathlon™).
• Conformance to established ISO standards for hemodialysis catheters.
  These are objective, established criteria for evaluating physical device performance.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI model, therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI model.

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